For a number of years, it seemed like drug company settlements would continue to rise every year. Fortunately, Johnson & Johnson’s $2.2 billion settlement reached last year (over conduct from the early 2000s) was the last >$1 billion payout. In 2014, there was plenty of action on the enforcement side, but over much smaller monetary figures.

Here are some of the notable articles we wrote on the enforcement side:

This past year saw CMS propose to change the Sunshine Act's specific CME exemption in July. This was met with hundreds of stakeholder comments arguing against such a change. CMS officially released their interpretation in their October Final Rule, seemingly maintaining the CME exemption through different sections of the Sunshine Act. In December, however, CMS released FAQs which muddled the water even more. Any changes to the Sunshine Act do not come into effect until 2016, with reporting not due until 2017, so we may have to wait out some more clarification from CMS.

December 29, 2014

On December 22, the United States filed a civil False Claims Act complaint against Omnicare Inc. alleging that it solicited and received kickbacks from Abbott Laboratories in exchange for purchasing and recommending Depakote, a dementia drug for elderly patients. Omnicare is the nation’s largest provider of pharmacy dispensing services to nursing homes, and also provides consulting services to the homes. According to the complaint, Omnicare “wielded enormous influence over the drugs administered to the residents of Omnicare-serviced nursing homes.” The U.S. alleges that “in exchange for Abbott’s kickbacks, Omnicare engaged in intensive efforts to convince nursing home physicians to prescribe Depakote, and its claims to federal healthcare programs for prescriptions of Depakote increased from less than $3 million in 1998 to over $92 million in 2008.”

Background

The Centers for Medicare and Medicaid Services (CMS) has issued regulations to ensure that nursing home residents are “free from unnecessary drugs,” including antipsychotic drugs used in excessive amounts, for excessive duration, without adequate monitoring, or in the presence of adverse consequences indicating that the dose should be reduced or discontinued. Nursing homes must ensure that the drugs are “necessary to treat a specific condition as diagnosed and documented in the clinical record” and that residents “receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated in an effort to discontinue these drugs.”

To comply with these requirements, nursing homes arrange for a consultantpharmacist to review the medications of each resident. During the course of these reviews, the consultant pharmacists make recommendations to remove, change, or add medications to the nursing home residents’ drug regimens. The defendant in this case, Omnicare, employed consultant pharmacists to make recommendations to physicians about the drugs they should prescribe for nursing home residents.

Allegations

According to the complaint, Omnicare's consultants recommended Depakote to help control aggressive behavior in dementia patients, and collected kickbacks from Abbott in return. Omnicare allegedly entered into agreements with Abbott to recommend Depakote over competitor drugs in exchange for “rebates” and other payments. "These payments undermined the independence of the consulting pharmacists and subverted their role of ensuring that nursing homes complied with [ ] regulations such that they, in fact, became an extension of the drug manufacturers’ sales forces," the complaint alleges.

The complaint uses a number of examples to connect Abbot's payments and rebates with specific Depakote sales targets. In a PowerPoint presentation describing contract terms, for instance, Abbott allegedly emphasized that rebate payments were contingent on meeting the threshold increases: “Rebates paid on total Depakote sales ONLY after achieving growth tiers.”

Omnicare also allegedly received annual educational grants, as well as money for data relating to sales of Depakote from Abbot. Omnicare allegedly solicited $50,000 to support a program called "Re*View," which the government claims did not exist. The complaint states that Omnicare internal documents referred to Re*View as the "one extra script per patient" program.

The U.S. concludes: "As a result of kickbacks paid by Abbott, Omnicare purchased, ordered, or recommended or arranged for the purchasing or ordering of Depakote, in violation of the federal anti-kickback statute...all of the claims Omnicare presented to Medicaid and Medicare for Depakote are false or fraudulent."

"Accordingly, Omnicare knowingly presented or caused to be presented false or fraudulent claims for payment or approval in violation of [the False Claims Act]."

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The allegations in this case are similar to a number of recent DOJ lawsuits. In May 2012, the United States, numerous individual states, and Abbott entered into a $1.5 billion resolution that, among other things, resolved Abbott’s civil liability under the False Claims Act for paying kickbacks to nursing home pharmacies. In 2013, as part of Johnson and Johnson's $2.2 billion settlement, Omnicare was implicated in a similar nursing home kickback arrangement.

Here, the United States filed its complaint against Omnicare in two consolidated whistleblower lawsuits filed under the False Claims Act in the Western District of Virginia. The whistleblower provisions of the False Claims Act authorize private parties to sue for fraud on behalf of the United States and share in any recovery. The United States is entitled to intervene and take over such lawsuits, as it did here.

December 23, 2014

In an effort by FDA to project its future areas of focus, the agency has put forth a strategic priorities document for 2014 through 2018. The document outlines FDA’s five strategic priorities—regulatory science, globalization, safety and quality, smart regulation, and stewardship—and establishes the agency’s core goals and objectives.

In a related blog post, FDA Commissioner Hamburg points out the agency’s increased roles and responsibilities. Numerous pieces of legislation illustrate her point, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the FDA Food Safety Modernization Act of 2011, the FDA Safety and Innovation Act of 2012, and the Drug Quality and Security Act of 2013.

“The many new responsibilities Congress has given FDA serve as an important backdrop for this plan, which includes a focus on advancing ways the Agency can continue to efficiently manage and build upon these new authorities. This will allow us to maintain our responsive and responsible stewardship of the public health for the 21st century,” Hamburg writes. She also notes the document has been in development for over a year, created by employees representing all areas of FDA’s offices and centers.

Underscoring the significance of the document’s priorities, Hamburg explains: “My hope is that these priorities, which will be repeatedly cited in our speeches, policies and writings, will serve as our foundational guidepost, providing the strategic direction to help the agency continue to provide the level of service and protection the American people deserve.”

FDA Cross-Cutting Strategic Priorities

I. Regulatory Science

FDA defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, or performance of FDA regulated products. In a previous 2011 Strategic Plan for Regulatory Science, FDA identified plans to close gaps in scientific knowledge required to support regulatory decision-making. Specifically, FDA uses this part of the report to highlight connections between regulatory science and tobacco policy. The agency is actively exploring ways to define the diversity of tobacco products and ultimately regulate their use as a public health measure.

II. Globalization

The last several decades have brought sweeping economic and technological changes improving conditions for global trade. 20 percent of all U.S. consumer spending is on FDA-regulated products and increasingly food and medical product ingredients come from overseas. FDA reports shipments regulated by the agency has more than tripled from 8 million import entry lines per year a decade ago to more than 29 million entry lines today.

FDA introduces four “pillars,” each serving as part of an international operating model. These include (1) information-sharing; (2) data-driven risk analytics; (3) enhanced intelligence; and (4) smart allocation of resources through partnerships. To achieve these goals, the agency is working with groups like the Global Coalition of Regulatory Science Research to develop a global data information system and network where regulators can regularly share real-time information and resources across markets. FDA seeks to allocate its resources based on a risk profile which is designed to leverage the efforts of government, industry, and public-and-private sector third parties.

III. Safety and Quality

FDA outlines safety and quality as including (1) the practices used to make products; (2) the integrity of the supply chain that delivers these products to their users; and (3) methods for protecting the public, including laboratory sample analyses for select product categories and product safety reporting systems. Recent legislation highlights FDA and Congressional response to foodborne illness, drug shortages, and unsafe manufacturing practices of compounded sterile drugs. This includes the FDA Food Safety Modernization Act (FSMA), FDA Safety and Innovation Act (FDASIA), and the Drug Quality and Security Act (DQSA).

FDA cites several steps it is taking to advance safety and quality across the agency. It points out the Case for Quality Initiative, which includes a voluntary compliance improvement program pilot and promotes medical device quality. Additionally, the planned Office of Pharmaceutical Quality will highlight and consolidate quality principles and review throughout the drug lifecycle. FDA will also continue to implement a lifecycle approach for biologics that spans early stage development through postmarket surveillance.

IV. Smart Regulation

FDA expresses a strong interest in maintain “public trust” in the agency’s ability to oversee regulated products. In order to keep this trust and maintain a global leadership role, FDA must foster what it calls “smart regulation”. These regulations are designed to attain the goal of protecting the public health while still encouraging innovation. The agency pledges to “remain dynamic,” continually responding to changing situations, new information, and new challenges by bringing to light the best possible science. In FDA’s view, regulation “done correctly” will do the following: (1) provide a pathway toward meaningful innovation; (2) instill consumer confidence in products and treatments; (3) level the playing field for businesses; (4) decrease the threat of litigation; and (5) prevent recalls that threaten industry reputation and consumer trust.

V. Stewardship

From personalized medicine and nanotechnology to the globalization of the food and medical product supplies to an array of new laws passed by Congress that expand FDA’s oversight responsibilities, these issues are not always supported by additional resources for FDA’s new responsibilities. Therefore, the agency places an emphasis on effectively and efficiently using limited resources to increase productivity while maintaining program integrity. FDA cites recruitment as an important element of this goal. By retaining a high-quality workforce, the agency and implement its program initiatives in the most efficient way. FDA also has established operational excellence and accountability objectives to align resource planning, allocation, and management with its strategic priorities to better ensure timely delivery of services that are critical to fulfilling FDA’s mission. Furthermore, FDA is looking at several projects that will enhance policy and strategy development and streamline operations, while maintaining the integrity of programs upon which the public relies, including re-organizing FDA’s regulatory and compliance activities around commodity-based and vertically integrated regulatory programs.

Mission Goals and Objectives

The five strategic priorities outline FDA’s vision for the coming years. FDA also lists mission goals and objectives to provide what it calls a “unifying structure for understanding how FDA’s various programs contribute to our mission to protect and promote public health.”

I. Enhancing Oversight of FDA-Regulated Products

FDA cites its oversight of production, manufacturing, the global supply chain, and post-market surveillance as critical steps to ensure compliance with statutory and regulatory requirements. To enhance its oversight, over the next four years the agency will pursue four objectives: (1) increase the use of regulatory science to inform standards development, analysis, and decision-making; (2) reduce risks in the manufacturing production, and distribution of FDA-regulated products; (3) strength detection and surveillance of problems with FDA-regulated products; (4) improve response to identified and emerging problems with FDA-regulated products.

Of note, FDA will be working closely with domestic and international partners to increase information sharing and enhance collaborations on compliance and training efforts to expand the collective safety net. In addition, DQSA gave FDA new tools to detect problems with certain prescription goods and track-and-trace products through the supply chain. With the staged implementation of Unique Device Identifiers over the next seven years, the information base concerning how marketed devices perform will enable more targeted actions to ensure the effectiveness of devices.

Additionally, FDA will continue to expand efforts to move from passive to active post-market surveillance system. For example, the Sentinel Initiative is a proactive system that complements existing systems that FDA has in place to track reports of adverse events linked to the use of our regulated products. The system enables FDA to actively query diverse automated health care data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely, while maintaining the privacy of patients. In addition, the National Medical Device Postmarket Surveillance Plan aims to strengthen the medical device postmarket surveillance system in the United States.

Because FDA regulates an array of products, there are numerous ways the agency creates standards to determine whether they should be put into the marketplace. To further this goal, over the next four years FDA will pursue three objectives: (1) increase regulatory science capacity to effectively evaluate products; (2) improve the effectiveness of the product development process; (3) improve predictability, consistency, transparency, and efficiency of the review process.

Scientific discoveries in fields ranging from genomics to bioinformatics can be applied during the development stages to improve the accuracy of tests that predict safety and effectiveness of potential medical products. FDA is looking toward new scientific fields to enhance the agency’s knowledge in the evaluation of drugs, biologics, and medical devices. FDA continues to focus on product development, as evident by the Drug Development Tools Qualification Program, which brings FDA scientists with external scientists and clinicians top develop and standardized biomarkers.

III. Promote Better Informed Decisions about the Use of FDA-Regulated Products

FDA stresses the need for there to be clear communication of its regulatory and scientific decisions, policies, and standards. It will continue to work in collaboration with partners both inside and out of the federal government to innovate and find ways to better disseminate information to the public. It hopes to achieve this goal by: (1) strengthening social and behavioral science to help patients, consumers, and professionals make informed decisions about regulated products; (2) improving patient and provider access to benefit-risk information about FDA-regulated products; and (3) improving safety and health information provided to the public.

FDA lists several ways it wants to improve safety and health information, including the implementation of strategies designed to improve consumer access to the use of nutrition information, expanded use of social media, conducting effective risk communications related to outbreaks and contamination incidents, and improved safety and health information for consumers with limited English proficiency.

IV. Strengthen Organizational Excellent and Accountability

FDA’s oversight is vast; the agency regulates trillions of dollars of economic activity each year. The agency stresses a commitment to being a good steward of resources, including both taxpayer dollars and user fees from industry, in achieving it mission. To further this end, FDA seeks to: (1) recruit, develop, retain, and strategically-manage a world-class workforce; (2) improve the overall operation and effectiveness of FDA; and (3) invest in infrastructure to enhance productivity and capabilities.

The agency describes its future approach as both horizontal and crosscutting in terms of management style, with a goal to improve overall operational effectiveness and efficiency. FDA expresses the goal of maintaining a culture of continual business process improvement, which the agency highlights in an economic lens as “adding value,” to the agency processes and public health community. Specifically, collaboration supporting scientific outreach, training, and research and development activities are designed to link FDA to other health agencies, including the academic community, consumers, and perhaps most important to industry: innovators, a group FDA wants to bring in as stakeholders in the regulatory process.